senior regulatory affairs manager (oncology).

about the company.

Our client, a world-class leading pharmaceutical manufacturing company, is currently looking for a Regulatory Affairs Manager (Oncology) to join their expanding team.

about the job.

• Independently lead and manage regulatory submissions, including CTA and NDA filings and obtain timely approval
  
  
• Maintain product registration certificates by timely submission and approval of variations and renewals
  
  
• Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements based on Hong Kong/Macau regulations, regional requirements and scientific and company policies and procedures
  
  
  

skills & experiences required.

• University graduate in Science or Pharmacy (preferably registered pharmacist in Hong Kong)
  
  
• Minimum 5 years of relevant experience in Regulatory Affairs for Hong Kong and Macau (Candidates with more experience may consider as Senior Manager)
  
  
• Must have Oncology experience
  ...